SANDOZ LOVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LOVASTATIN

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

C10AA02

INN (Kansainvälinen yleisnimi):

LOVASTATIN

Annos:

40MG

Lääkemuoto:

TABLET

Koostumus:

LOVASTATIN 40MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0120669001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2019-08-01

Valmisteyhteenveto

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_Sandoz Lovastatin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR SANDOZ LOVASTATIN
Lovastatin Tablets USP
20 mg and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision: March 20, 2014
Submission Control Number: 172518
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_Sandoz Lovastatin _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOGY
............................................